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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM go.Now

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  Class 2 Device Recall SOMATOM go.Now see related information
Date Initiated by Firm July 31, 2019
Create Date August 28, 2019
Recall Status1 Terminated 3 on December 02, 2020
Recall Number Z-2399-2019
Recall Event ID 83556
510(K)Number K173632  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM go.Now;
Models #11061610 & 11061618

Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

Code Information All serial numbers
Recalling Firm/
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Rebecca Tudor
Manufacturer Reason
for Recall
The injector holder could potentially fall off together with the injector and the storage box.
FDA Determined
Cause 2
Nonconforming Material/Component
Action 1. Take special care when rotating the injector and storage box horizontally 2. Your Siemens Healthineers service engineer will perform an on-site check to evaluate the stability of the injector arm. 3. If there is any problem with the injector arm, your Siemens Healthineers service engineer will replace the injector arm with an improved intermediate version free of charge. 4. Please ensure all users of the affected products are aware. 5. Retain this notification in your product related records and place a copy in the medical device's instructions for use. 6. If you have distributed this product, identify your customers and notify them. If you wish to request an earlier appointment or have additional questions, feel free to contact service organization at 1-800-888-7436 .
Quantity in Commerce 0
Distribution US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = Siemens Medical Solutions USA, Inc.